A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)

NCT04626596 | Completed Phase 3 FDA Drug FDA Device

• 3 other identifiers: 8415-0602020-001232-95MK-8415-060
• Study Type: interventional
• Target: 498
• Locations: 2 countries
• Sites: 67

Brief Summary

The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.

Conditions

Contraception

Outcome Measures

Primary Outcomes (4)

• Pregnancy Rate (Pearl Index) for At Risk Cycles During Extended-Duration Use

  The Pearl Index is expressed as the number of on-treatment pregnancies per 100 woman-years of exposure. An on-treatment pregnancy is defined as a confirmed pregnancy with an estimated date of conception 36 months to 60 months since the date of implant insertion. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "at risk" cycles for conception will be included in this Pearl Index calculation. An at risk cycle is defined as a cycle during which participants with ENG implant had affirmed heterosexual intercourse without the use of additional contraception.

  Up to 24 months

• Pregnancy Rate (Pearl Index) for Alternative At Risk Cycles During Extended-Duration Use

  The Pearl Index is expressed as the number of on-treatment pregnancies per 100 woman-years of exposure. An on-treatment pregnancy is defined as a confirmed pregnancy conceived with an estimated date of conception 36 months to 60 months since the date of implant insertion. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "alternative at risk" cycles will be included in this Pearl Index calculation. An alternative at risk cycle is defined as a cycle in which participants with ENG implant did not use additional contraception, but without the requirement for affirmed heterosexual intercourse.

  Up to 24 months

• Number of Participants Who Experience One or More Adverse Events During Extended-Duration Use

  An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to approximately 27 months

• Number of Participants Who Discontinue Treatment (Implant Removed) Due to an Adverse Event During Extended-Duration Use

  An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to approximately 24 months

Secondary Outcomes (16)

• Pregnancy Rate (Pearl Index) for At Risk Cycles During Year 4 of Implant Use

  Up to 12 months

• Pregnancy Rate (Pearl Index) for At Risk Cycles During Year 5 of Implant Use

  Up to 12 months

• Cumulative Pregnancy Rate During 5 Years of Implant Use

  Up to 60 months (From 3 years prior to study entry to 2 years after study entry)

• Cumulative Pregnancy Rate During 4 Years of Implant Use

  Up to 48 months (From 3 years prior to study entry to 1 year after study entry)

• Pregnancy Rate (Pearl Index) for At Risk Cycles During 5 Years of Implant Use

  Up to 60 months (From 3 years prior to study entry to 2 years after study entry)

Study Arms (1)

ENG implant

EXPERIMENTAL

Participants will have the ENG 68 mg implant inserted and in place for 36 months before enrollment. The ENG implant will remain in place for an additional 24 months.

Combination Product: Radiopaque Etonogestrel (ENG) Implant

Interventions

Radiopaque Etonogestrel (ENG) Implant COMBINATION_PRODUCT

68 mg subdermal implant

Also known as: Org 32222, Nexplanon, Implanon-NXT, SCH900415, MK-8415

ENG implant

Eligibility Criteria

• Age: Up to 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Not diagnosed with perimenopause or menopause.
• Heterosexually active with a partner who is not known to be subfertile, sterilized, or infertile, and is seeking contraception for pregnancy.
• Palpable intact ENG implant in the upper inner-arm for 36 months from the date of insertion at the time of enrollment, and has documentation of the insertion date (for example, Nexplanon user card or medical record completed on the date of insertion).
• Does not desire a pregnancy within the 24 months after enrollment, is willing to continue use of the implant for an additional 24 months, and is not intending to use any other form of contraception (eg, condoms) from enrollment until after implant removal at 24 months post enrollment.
• Good physical and mental health in the medical judgment of the investigator.
• History of regular menstrual cycles of 21 to 35 days before the insertion of the ENG implant or before hormonal contraceptive use (which may have preceded the current implant use).
• Able and willing to adhere to all required study procedures, including study visits and eDiary entries, and not planning to relocate during the study.

You may not qualify if:

• Conceived a pregnancy during use of the current implant or a past contraceptive implant.
• Known or suspected pregnancy at the time of screening or enrollment visit.
• History of subfertility or infertility.
• Breastfeeding.
• Untreated gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis.
• Significantly abnormal cervical cytology (Pap) or pathology results either at screening or documented in the 36-month period prior to enrollment.
• Current use of an intrauterine device/intrauterine system (IUD/IUS).
• Presence of more than one ENG implant.
• Use of daily/monthly hormonal contraceptives, sex steroids, or GnRH agonist/antagonist within 3 months prior to enrollment.
• Use of injectable hormonal contraceptive with 3-month duration within 9 months prior to enrollment.
• Use of injectable GnRH agonist with 3-month duration within 10 months prior to enrollment .
• Use of medications that induce liver enzymes within 2 months prior to enrollment.
• Untreated or unresolved vaginal bleeding or spotting attributable to underlying pathology in the 12 months before screening.
• Frequent, prolonged, or excessive vaginal bleeding/spotting in the 12 months prior to screening which has not been evaluated to detect underlying pathology.
• History of venous thromboembolism or arterial thromboembolism, transient ischemic attack, angina pectoris, or claudication.

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (67)

Alabama Clinical Therapeutics (Site 0222)

Birmingham, Alabama, 35205, United States

Location

Desert Star Family Planning (Site 0193)

Phoenix, Arizona, 85015, United States

Location

Precision Trials (Site 0187)

Phoenix, Arizona, 85032, United States

Location

Visions Clinical Research Tucson (Site 0134)

Tucson, Arizona, 85712, United States

Location

Essential Access Health (Site 0163)

Los Angeles, California, 90010, United States

Location

Matrix Clinical Research Inc (Site 0105)

Los Angeles, California, 90057, United States

Location

University of California Los Angeles (Site 0119)

Los Angeles, California, 90095, United States

Location

University of California, Davis (Site 0124)

Sacramento, California, 95817, United States

Location

Stanford University (Site 0112)

Stanford, California, 94305, United States

Location

Planned Parenthood of the Rocky Mountains (Site 0196)

Denver, Colorado, 80207, United States

Location

Comprehensive Womens Health Center (Site 0194)

Denver, Colorado, 80230, United States

Location

Physicians' Research Options, LLC (Site 0166)

Lakewood, Colorado, 80228, United States

Location

University Of Florida (Site 0144)

Jacksonville, Florida, 32207, United States

Location

Emerald Coast Obstetrics and Gynecology (Site 0203)

Panama City, Florida, 32405, United States

Location

Lenus Research & Medical Group Llc (Site 0102)

Sweetwater, Florida, 33172, United States

Location

Comprehensive Clinical Trials LLC (Site 0101)

West Palm Beach, Florida, 33409, United States

Location

Mount Vernon Clinical Research (Site 0111)

Sandy Springs, Georgia, 30328, United States

Location

Rosemark (Site 0177)

Idaho Falls, Idaho, 83404, United States

Location

Planned Parenthood of Illinois (PPIL) (Site 0200)

Chicago, Illinois, 60610, United States

Location

Indiana University (Site 0220)

Indianapolis, Indiana, 46202, United States

Location

McFarland Clinic, PC (Site 0217)

Ames, Iowa, 50010-3014, United States

Location

Cypress Medical Research Center (Site 0226)

Wichita, Kansas, 67226, United States

Location

Southern Clinical Research Associates (Site 0219)

Metairie, Louisiana, 70001, United States

Location

Johns Hopkins Bayview Medical Center (Site 0225)

Baltimore, Maryland, 21224, United States

Location

Boston University Medical Center (Site 0167)

Boston, Massachusetts, 02118, United States

Location

Planned Parenthood League of Massachusetts (Site 0135)

Boston, Massachusetts, 02215, United States

Location

Michigan Medicine (Site 0108)

Ann Arbor, Michigan, 48109, United States

Location

Saginaw Valley Medical Research Group, LLC (Site 0198)

Saginaw, Michigan, 48604, United States

Location

Planned Parenthood of North Central States (PPNCS) (Site 0113)

Minneapolis, Minnesota, 55408, United States

Location

Metro Jackson OBGYN/SKYCRNG (Site 0233)

Jackson, Mississippi, 39202, United States

Location

Planned Parenthood of the Saint Louis Region & Southwest Missouri (Site 0158)

St Louis, Missouri, 63108, United States

Location

Washington University (Site 0129)

St Louis, Missouri, 63108, United States

Location

Office of Edmond Pack, MD (Site 0168)

Las Vegas, Nevada, 89113, United States

Location

Capital Health OB/GYN- Lawrenceville (Site 0190)

Lawrenceville, New Jersey, 08648, United States

Location

Albuquerque Clinical Trials (Site 0210)

Albuquerque, New Mexico, 87102, United States

Location

Bosque Women's Care (Site 0211)

Albuquerque, New Mexico, 87111, United States

Location

Icahn School of Medicine at Mount Sinai (Site 0155)

New York, New York, 10029, United States

Location

Columbia Univ. Medical Center (Site 0118)

New York, New York, 10032, United States

Location

Montefiore Medical Center (Site 0103)

The Bronx, New York, 10461, United States

Location

Carolina Women's Research and Wellness Center (Site 0154)

Durham, North Carolina, 27713, United States

Location

Eastern Carolina Women's Center (Site 0159)

New Bern, North Carolina, 28562, United States

Location

Velocity Clinical Research, Cincinnati (Site 0230)

Cincinnati, Ohio, 45242, United States

Location

The Ohio State University (Site 0176)

Columbus, Ohio, 43210, United States

Location

HWC Women's Research Center (Site 0199)

Englewood, Ohio, 45322, United States

Location

Oregon Health Sciences University Hospital (Site 0128)

Portland, Oregon, 97239, United States

Location

OB/GYN Associates of Erie (Site 0183)

Erie, Pennsylvania, 16507, United States

Location

University of Pittsburgh - Magee Womens Hospital (Site 0100)

Pittsburgh, Pennsylvania, 15213, United States

Location

Palmetto Clinical Research (Site 0133)

Summerville, South Carolina, 29485, United States

Location

University of Tennessee Medical Center Knoxville (Site 0218)

Knoxville, Tennessee, 37920, United States

Location

Gadolin Research (Site 0232)

Beaumont, Texas, 77702, United States

Location

Signature Gyn Services (Site 0201)

Fort Worth, Texas, 76104, United States

Location

Planned Parenthood of the Gulf Coast (Site 0106)

Houston, Texas, 77023, United States

Location

University of Texas Health Science Center (Site 0178)

Houston, Texas, 77030, United States

Location

Centex Studies, Inc. (Site 0171)

Houston, Texas, 77058, United States

Location

Advances in Health, Inc. (Site 0209)

Pearland, Texas, 77030, United States

Location

Tekton Research - Floyd Curl Drive (Site 0228)

San Antonio, Texas, 78229, United States

Location

Physicians' Research Options, LLC (Site 0204)

Pleasant Grove, Utah, 84062, United States

Location

JBR Clinical Research (Site 0174)

Salt Lake City, Utah, 84107, United States

Location

Tidewater Clinical Research Inc (Site 0162)

Norfolk, Virginia, 23502, United States

Location

Eastern Virginia Medical School (Site 0146)

Norfolk, Virginia, 23507, United States

Location

Multicare Health System Institute for Research and Innovation (Site 0188)

Cheney, Washington, 99004, United States

Location

Seattle Women's: Health, Research, Gynecology (Site 0149)

Seattle, Washington, 98105, United States

Location

Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky (Site 0110)

Seattle, Washington, 98122, United States

Location

North Spokane Women's Clinic (Site 0137)

Spokane, Washington, 99207, United States

Location

Advance Medical Concept PSC (Site 0313)

Cidra, PR, 00739, Puerto Rico

Location

Clinical Research Puerto Rico Inc (Site 0302)

San Juan, PR, 00909, Puerto Rico

Location

FDI Clinical Research (Site 0305)

San Juan, PR, 00927, Puerto Rico

Location

MeSH Terms

Interventions

Endoglin; Drug Implants; etonogestrel

Intervention Hierarchy (Ancestors)

Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Clinical Lead

  Organon and Co

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: November 19, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (64); PR (3)